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Quality Management Systems Documentation Specialist

1 month ago

Bengaluru Rural, India Infinitalent Consulting (P) Ltd Full time

At Infinitalent Consulting (P) Ltd, we are seeking a highly skilled Quality Management Systems Documentation Specialist to join our team. As a key member of our quality assurance team, you will be responsible for ensuring compliance with quality management system standards and documenting all quality-related processes.

Key Responsibilities:

  • Handling quality events in production department, including Change Control, Deviation, OOS, OOT, CAPA, and investigation.
  • Preparation of Equipment Performance qualification protocol and report.
  • Providing data to QA to prepare Process Validation Protocol and report.
  • Preparation of Batch Manufacturing Record (BMR), Master Formula Record (MFR), and Standard Operating Procedures (SOP) related to Production department.
  • Coordinating the preparation, review, approval, and distribution of production-related documents, including BMRs, SOPs, investigation reports, and Change control forms.
  • Training production staff on SOP, BMR, CAPA, and proper documentation practices.
  • Collaborating with cross-functional teams, including R&D, QC, QA, Maintenance, Stores, and Commercial for data collection and document review.
  • Participating in quality reviews and investigations as needed.
  • Supporting internal and external audits and inspections by preparing documentation, facilitating document retrieval, and addressing auditor inquiries.
  • Maintaining the storage, retrieval, and archival of production documentation, ensuring documents are stored securely and are readily accessible for audits, inspections, and other quality assurance activities.
  • Reviewing Batch Manufacturing Record & Batch Packing Record for completeness on a weekly basis.
  • Reviewing production log books, including equipment usage log books, clean room usage log books, weighing balance performance log books, and daily humidity recording log books.
  • Coordinating with external agencies for calibration of Production department temperature and relative humidity instruments, weighing balances, and standard weights.
  • Obtaining line clearance for clean room from QA for product change over.